Comparing Intravenous and Oral Paracetamol for Cholecyste... | NCT00292214

Studies
Comparing Intravenous and Oral Paracetamol for Cholecystectomy

NCT00292214

Sponsor

Melbourne Health

Status

Completed

Last Update Posted

Mar 9, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Laparoscopic Cholecystectomy

Interventions

Paracetamol (acetaminophen)

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Oct 2006

First Submitted Date

Feb 13, 2006

First Submission Date that Met QC Criteria

Feb 13, 2006

First Posted Date

Feb 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2007

Last Update Posted Date

Mar 9, 2007Estimated

Description Module

Brief Summary

To determine the amount of paracetamol in the blood when given in either intravenous or oral forms prior to cholecystectomy. The clinical effectiveness of each form will also be evaluated with pain scores and the use of other pain relief drugs.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Paracetamol (acetaminophen)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations

Secondary Outcomes

Measure	Description	Time Frame
Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females aged 18-75
Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia

Exclusion Criteria:

Inadequate English comprehension (difficult to obtain informed consent and cooperation), and when interpreters are not available.
History of allergy or sensitivity to paracetamol
Administration of oral paracetamol within previous 8 hours
American Society of Anesthesiologists (ASA) grade IV or V, indicating serious cardio-respiratory co-morbidity
Not suitable for protocol anaesthetic technique (eg: history of nausea and vomiting with morphine)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malcolm Hogg, Anaesthetist	Melbourne Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Melbourne Hospital		Melbourne	Victoria	3052	Australia

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia
D010146	Pain

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided